Greg Koski, M.D., Ph.D., Director, Office for Human Research Protections, OS, DHHS
Dr. Koski noted that his office is trying to move toward a new paradigm in how to approach human subjects research. He noted a need for greater flexibility in review, approval, and oversight of human research. There also needs to be a more accountable process, so that as institutions exercise their responsibilities in a more flexible environment, they recognize that they will be held accountable.
OHRP will work with all government agencies involved in human research to achieve four goals: 1) greater simplicity in regulations, 2) harmonization of policies across different government agencies; 3) greater efficiency of the process, and 4) development of an effective process.
OHRP has implemented a unified federal registration system for institutional review boards. The system is voluntary, but the FDA is moving toward making it a requirement. It will provide information on where institutional review boards are, how they are constituted, and what kind of work they are reviewing. The system can also communicate changes to policies and regulations.
OHRP has also implemented a dramatically simplified federalwide assurance process that replaces all other assurances. The new process affords enormous opportunities for collaboration. This is the first step in uncoupling the IRB process from the institutional assurance process. Dr. Koski envisions the increasing use of centralized boards for review and approval of particular studies.
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